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Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 00:54:45 GMT)
CTRI Number CTRI/2014/10/005154 [Registered on: 30/10/2014] - Trial Registered Prospectively Last Modified On 27/08/2016 Post Graduate Thesis No Type of Trial Interventional Type of Study Ayurveda Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study Role of Barley in the treatment of Kidney Stones Scientific Title of CLINICAL STUDY TO ASSESS THE THERAPEUTIC PROPERTIES OF AYURVEDIC Study FORMULATION OF HORDEUM VULGARE (Yava) IN THE MANAGEMENT OF RENAL CALCULI Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr K V Chakradhar Trial Coordinator (multi-center study) Designation Ph.D Scholar Affiliation Sri Venkateswara Ayurvedic Medical College and Hospital Address Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati Chittoor ANDHRA PRADESH 517501 India Phone 919494100913 Fax 08772240035 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr K V Chakradhar Query) Designation Ph.D Scholar Affiliation Sri Venkateswara Ayurvedic Medical College and Hospital Address Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati Chittoor ANDHRA PRADESH 517501 India Phone 919494100913 Fax 08772240035 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr S Dattatreya Rao Designation Professor and Head Affiliation Sri Venkateswara Ayurvedic Medical College and Hospital Address Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati
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Chittoor ANDHRA PRADESH 517507 India Phone 91929133655 Fax 08772240035 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Sri Venkateswara Ayuvedic Medical College and Hospital Tirupati Primary Sponsor Primary Sponsor Details Name Dr K V Chakradhar Address Ph.D. Scholar Department of Shalya Sri Venkateshwara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati Type of Sponsor Other [Investigator initiated] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr KV Chakradhar Department of Shalya Sri Venkateswara 919494100913 Ayurvedic Medical College and Hospital [email protected] Tirupati m Chittoor ANDHRA PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 05/10/2014 No Committee of Sri Venkateswara Medical College Tirupati Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Patients suffering with all types of Renal Calculi Intervention / Type Name Details Comparator Agent Intervention Hordeum vulgare (Yava) This is an alkali substance, which is being prepared from the breads of barley with the procedure of K??ra Nirm??a Vidhi (SusrutaSamhita). Dry Yava Panc??ga (Whole plant of Barley) is divided into small pieces, ignited by sesame stalks (Tila oil plant) with pebbles of limestone. When the fire has burnt out, the ash and the slake lime should be collected separately. Then one Dro?a (12.288 Kgs) of the ash should be dissolved in six Dro??s of
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water and filtered 21 times and should be treated on fire in a big pan, while it is slowly stirred by a ladle. When it becomes clear, red, sharp and slimy, it should be filtered through a wide piece of cloth and the filtrate should be placed again on fire after removing the separated residue. This is the basic Yava kshara (alkali of Barley) which serve the main purpose. The pH of the final product is 11.2. 4 doses of the drug each consisting 250 mg was administered orally on weekly basis after mixing the drug in 200 ml of water. Inclusion Criteria Inclusion Criteria Age From 16.00 Year(s) Age To 60.00 Year(s) Gender Both Details • Sex: Either sex
• Radiological evidence of stone (>5 mm to <10 mm) in Kidney, Ureter and Urinary Bladder.
Exclusion Criteria Exclusion Criteria Details • Stone size more than 10 mm. • Impacted stone. • Gross Hydronephrosis. • Pyelonephritis. • Uncontrolled Diabetic Mellitus and Hypertension • Malignancy. • Impaired Renal Function. • Poorly Functioning Kidney. • Patients with obstruction in urinary passage. • Patients with known metabolic abnormality for calculus formation (Hyperuraecemia). • Any other complication of calculus. • Patients undergoing treatment for any other serious illness.
Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints 1. expulsion of the renal calculi 90 days Secondary Outcome Outcome Timepoints 1. ability in reducing the size of the calculi 90 days 2. Improved quality of life
Target Sample Size Total Sample Size=100 Sample Size from India=100 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 4 Date of First 01/12/2014
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Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Study outcome will be published in peer reviewed journals Brief Summary The incidence of renal calculi (urolithiasis) is increasing in both developed and developing countries. It is estimated that 12% of world population experiences renal stone disease with a recurrence rate of 70-80% in males and 47-60% in females. Urolithiasis carries high risk of recurrence after the initial episode, of around 50% at 5 years and 70% at 9 years. Search for alternative medicines available at low cost which exhibit least adverse effects are anticipated to benefit many poor patients with renal calculi. It has been described in Ayurveda that Hordeum vulgare is effective in the expulsion of renal calculi. Su?ruta the father of surgery explained urinary calculus under the heading of Ashmari in details including etiological factors, classification, symptomatology, pathology, complications and its management in a most scientific manner. This disease is dreadful and hence considered one of the ‘Mah?gad?s’ by Su?ruta, may be owing to its potentiality to disturb the anatomy and physiology of urinary system. The old bladder stone is reported at “ELAMARAH” in Upper Egypt, dated about 4800 BC, shows that humans of ancient time were undoubtedly affected with the disease Ashmari just as humans are now. ?igveda and Atharavaveda (2000 – 5000 BC) also mentioned the stone and advise people not to ride a horse, Caraka has advised medical management and Su?ruta advised both conservative and surgical removal of stone through perineal root cystolithotomy. All the Acharyas except Charaka have classified the disease M?tr??mari into four types.
i.e. i.) Shleshmaja Ashmari
ii.) Pittaja Ashmari
iii.) Vataja Ashmari
iv) Shukraja Ashmari
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Management of various types of Ashmari has been described in Su?ruta Samhit? in view of the fatality of the diseases treatment has been advised to be undertaken in the early stages of the disease. Gh?ta recipes for three types of calculi have been mentioned along with indication of appropriate food, drinks and other measures, where he exclusively described about the usage of Yava Kshara. Indication for the surgical management has been given along with a note of caution regarding its dangers and doubtful chances of success. It was to be undertaken only on failure of conservative treatment and when death was inevitable if not treated surgically. However, there is no comprehensive analysis and the formulation has not been scientifically validated. Ours is the first attempt to validate the formulation described in Ayurveda. Development of new formulations which are likely to be cheaper and exhibit minimal or no adverse effects will be beneficial. The preliminary results advocate undertaking systematic scientific studies of the Hordeum vulgare formulation in the management of renal calculi. In view of the above facts and also the existing clinical trial data, it is proposed to validate the formulation through systematic studies.
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